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A major British clinical trial has found hydroxychloroquine has “no benefit” for patients hospitalized with COVID-19, scientists said Friday, in the first large-scale study to provide results for a drug at the center of political and scientific controversy.

Hydroxychloroquine, a decades-old malaria and rheumatoid arthritis drug, has been touted as a possible treatment for the new coronavirus by high profile figures, including US President Donald Trump, and has been included in several randomized clinical trials.

The University of Oxford’s Recovery trial, the biggest of these so far to come forward with findings, said that it would now stop recruiting patients to be given hydroxychloroquine “with immediate effect”.

“Our conclusion is that this treatment does not reduce the risk of dying from COVID among hospital patients and that clearly has a significant importance for the way patients are treated, not only in the UK, but all around the world,” said Martin Landray, an Oxford professor of medicine and epidemiology who co-leads the study.

The randomized clinical trial—considered the gold standard for clinical investigation—has recruited a total of 11,000 patients from 175 hospitals in the UK to test a range of potential treatments.

Other drugs continuing to be tested include: the combination of HIV antivirals Lopinavir and Ritonavir; a low dose of the steroid Dexamethasone, typically used to reduce inflammation; antibiotic Azithromycin; and the anti inflammatory drug Tocilizumab.

Researchers are also testing convalescent plasma from the blood of people who have recovered from COVID-19, which contains antibodies to fight the virus.

Researchers said 1,542 patients were randomly assigned to hydroxychloroquine and compared with 3,132 patients given standard hospital care alone.

They found “no significant difference” in mortality after 28 days between the two groups, and no evidence that treatment with the drug shortens the amount of time spent in hospital.

“This is a really important result, at last providing unequivocal evidence that hydroxychloroquine is of no value in treatment of patients hospitalized with COVID-19,” said Peter Openshaw, a professor at Imperial College London, in reaction to the results.

He added that the drug was “quite toxic” so halting the trials would be of benefit to patients.

Hydroxychloroquine has been in use for years but it has a number of potentially serious side effects, including heart arrhythmia.

Researchers from the Recovery trial said they would share their data with the World Health Organization (WHO), which on Wednesday restarted its own trials of hydroxychloroquine.

They were temporarily halted last month because of a now-retracted observational study in The Lancet medical journal that had suggested hydroxychloroquine and chloroquine, a related compound, were ineffective against COVID-19 and even increased the risk of death.

Authors of The Lancet research said on Thursday that they could no longer vouch for the integrity of its underlying data, in the face of serious concerns raised by fellow scientists over a lack of clarity about the countries and hospitals that contributed patient information.

The scandal cast a shadow over The Lancet and another top medical journal, but it did nothing to clear up the increasingly politicized question of whether or not hydroxychloroquine works as a treatment for COVID-19.

Openshaw said the Recovery trial should be credited with continuing the research until they could reach a definitive conclusion on hydroxychloroquine.

“Everyone regrets that it doesn’t work, but knowing that allows us to focus on finding drugs that actually help recovery from COVID-19,” he added.

Oxford professor Peter Horby, the lead investigator on the Recovery Trial, said there was probably a “very large number” of people around the world taking hydroxychloroquine for COVID-19, with countries including the US, China and Brazil authorizing it.

A separate clinical trial on Wednesday in the US and Canada found that taking hydroxychloroquine shortly after being exposed to COVID-19 does not work to prevent infection significantly better than a placebo.

Covid-19 research scam: Unwanted diversion during pandemic – The East African

The first research scandal of the coronavirus pandemic has created unnecessary distraction around the politically divisive drug hydroxychloroquine, scientists say, as questions swirl around the tiny health care company at the centre of the affair.

On Thursday, most of the authors of major studies that appeared in The Lancet and the New England Journal of Medicine (NEJM) retracted their work and issued apologies, saying they could no longer vouch for their data after the firm that supplied it — Chicago-based Surgisphere — refused to be audited.

NEW DIMENSIONS

At any other time, the matter might have led to hang-wringing within academia, but it has taken on a new dimension as the world grapples with a virus that has claimed some 400,000 lives.

Of particular interest was the paper in The Lancet that claimed to have analysed the records of 96,032 patients admitted to 671 hospitals across six continents, finding that hydroxychloroquine showed no benefit and even increased the risk of death.

Its withdrawal is seen as a boost to backers of the decades-old anti-malarial drug, who include US President Donald Trump and his Brazilian counterpart Jair Bolsonaro.

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“It’s very politicised — there is a group, probably not particularly small, who have learned to mistrust science and scientists, and this just feeds into that narrative,” Gabe Kelen, a professor of emergency medicine at Johns Hopkins University, told AFP.

This is despite the fact that even without The Lancet paper, evidence has been building against hydroxychloroquine’s use against Covid-19.

HUMAN EXPERIMENTS

On Friday, results from a fourth randomised controlled trial — carefully designed human experiments considered the most robust form of clinical investigation — showed it had no impact against the virus.

The Lancet, which first published in 1823, is one of the world’s most trusted medical journals.

As a result, the hydroxychloroquine paper had an outsized impact: the World Health Organization, Britain and France all suspended ongoing clinical trials.

But things soon began unravelling after researchers noticed numerous red flags, from the huge number of patients involved to the unusual level of detail about the doses they had received.

PRESTIGIOUS

Both The Lancet and the equally prestigious NEJM, which had published a paper on whether blood thinners elevated the risk of Covid-19 that relied on the same company, issued expressions of concern — before the authors themselves pulled both papers.

Surgisphere, founded in 2007 by vascular surgeon Sapan Desai, had refused to share data with third-party reviewers, saying it would violate privacy agreements with hospitals.

However, when science news site The Scientist began reaching out to hospitals throughout the US to ask whether they had participated, it found none.

Surgisphere’s internet profile has also raised numerous questions. Only a handful of employees could be found on LinkedIn, and most have now deactivated their accounts.

MEDICAL MALPRACTICE

According to the Guardian newspaper, its employees included an adult model and until last week the contact page on its website redirected to a WordPress template for a cryptocurrency website, leaving it unclear how hospitals could have reached out to them.

Meanwhile Desai, who according to court records has three outstanding medical malpractice suits against him, has written extensively in the past on research misconduct.

“The most serious cause of fraud in medical publishing is manufactured data that authors use to support high impact conclusions,” he said in a 2013 paper.

For Ivan Oransky, who founded Retraction Watch in 2010, the affair is far from surprising, serving instead to highlight systemic issues in science publishing and the way science is reported to the public.

“No one took a hard look at the data,” said Oransky. “But we’ve known about these issues for literally decades.”

LEADING JOURNALS

Policymakers should get away from the idea of using the results of a single study to inform their decisions, he added, as was the case for the WHO — and the media has a responsibility to place papers in context instead of hyping them up.

The problem also stems from the fact that even leading journals rely too heavily on an honour system, but “you never know when a catastrophe is going to happen, if you’re not willing to put into place some reasonable safeguards,” added Oransky.

As to the future, the current episode is unlikely to serve as a wake-up call, he said. If one journal increases its diligence, more blockbuster papers will start appearing in its competitors.

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